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February 21, 2026Canadian Journal of Surgery0 citationsOpen Access

Assessing the fragility index of randomized controlled trials on carotid artery stenosis: a systematic review

ELEva LiuNTN TilburyAZAmy Zhou

Key Result

Randomized trials comparing carotid endarterectomy to stenting have low fragility indices with loss to follow-up exceeding FI, questioning result robustness.

Key Points

  • The research aims to evaluate the fragility index of randomized controlled trials on carotid artery stenosis to understand the stability of their findings.
  • Conducted a systematic review of randomized controlled trials on carotid artery stenosis.
  • Assessed the fragility index for comparisons between carotid endarterectomy (CEA) and carotid artery stenting (CAS).
  • Analyzed long-term follow-up (LTFU) data to evaluate robustness of trial results.
  • Found that few events could change results from significant to nonsignificant.
  • Identified that all studies reported LTFU greater than their fragility index, questioning result reliability.

Structured PICO

Are the statistically significant results of RCTs comparing carotid endarterectomy and carotid artery stenting robust when assessed by the fragility index?

P
Population
5,296 patients from 11 RCTs with carotid artery stenosis
I
Intervention
Carotid endarterectomy (CEA)
C
Comparator
Carotid artery stenting (CAS)
O
Outcome
Fragility index (FI) of statistically significant dichotomous primary outcomes

The statistically significant results of RCTs comparing carotid endarterectomy and carotid artery stenting are fragile, as the loss to follow-up exceeded the fragility index in all reporting trials.

Limitations

  • FI assesses only dichotomous outcomes
  • Excluded studies reporting continuous outcomes
  • No accepted FI classification system
  • Variable follow-up time in the included studies

Abstract

A small number of events is required to change the findings of RCTs comparing CEA to CAS from statistically significant to statistically nonsignificant. All studies that reported LTFU had LTFU greater than its FI, calling into question the robustness of these results.

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Cite This Study

Liu et al. (2026) studied this question. Randomized trials comparing carotid endarterectomy to stenting have low fragility indices with loss to follow-up exceeding FI, questioning result robustness.

synapsesocial.com/papers/69994bdd873532290d01fed9https://doi.org/10.1503/cjs.008525
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